Seraseq® Trisomy 21 Male - Matched Reference Material (Lyophilized)

The Seraseq T21 Male - Matched Reference Material (Lyophilized) is a reference material intended for use in the development, validation, and evaluation of routine performance monitoring of Non-Invasive Prenatal Testing/Screening (NIPT /NIPS) using circulating cell-free DNA (cfDNA) in maternal blood to screen for fetal chromosomal aneuploidies such as Trisomy 21 (Down Syndrome). This reference material is suitable for use by clinical laboratories, research institutions, and diagnostic assay developers to ensure consistent and reliable results across different sequencing runs and laboratory conditions.

This material is provided as a lyophilized powder and needs to be reconstituted with 1 mL molecular grade water, followed by extraction of ccfDNA before use in molecular assays.

Documents

• Package Insert for Seraseq Trisomy 21 Male Matched Reference Material (Lyophilized) (Package Insert)
• Seraseq NIPT Reference Materials Non-Requirement Letter (SDS Non-Requirement Letter)

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